A review of the aquabeam robotic system's log file could not be conducted as the date when the aquablation procedure took place is unknown.A review of the device history record (dhr) for serial number (b)(4) was performed, which confirmed that there were no nonconformance's, failures, discrepancies, or missed steps during the manufacturing process that could be related to the reported event.The review indicated that the device met all design and manufacturing specifications when released for distribution.Aquabeam robotic system user manual, um220101, was reviewed and states the following: procedure: as with any surgical urologic procedure, potential risks of the aquablation procedure include: infection.A historical review for similar complaints confirmed one other similar event for sepsis have been reported to procept biorobotics.A root cause for the reported event could not be determined.The aquabeam robotic system user manual lists infection as a potential risk of the aquablation procedure.No device malfunction was reported or confirmed through the investigation performed by procept.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.
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